CARMINE J. DEFILIPPIS, P.E.
205 Whitney Oaks Lane
Morrisville, North Carolina 27560
919-651-9393 (H), 805-558-6025 (C)
Email: cjdefilippis[at]hotmail.com
SUMMARY
Senior Engineering Manager with hands on experience in bio/pharmaceutical operations, engineering and facilities design/construction/qualification with an extensive background in facilities operations, project management, capital planning and site master planning. Recognized for meeting or exceeding objectives.
PROFESSIONAL EXPERIENCE
AMGEN, INC 2006 2009
Director of Engineering, Thousand Oaks, CA
Directed project-engineering group in $1+Billion-capital program. Provided discipline leadership for all capital projects including manufacturing, R+D laboratories and infrastructure projects resulting in cost savings of greater than $1MM.
Managed supplemental staffing procurement program including MSA and service providers resulting in reduced man hour rates and immediate workplace availability.
Led Global Engineering Committees and cross-functional teams including operations, QC, risk management, EH+S and FM insurance providers eliminating cross-site duplication and improved project due diligence and process controls.
Authored-Project Engineering Quality Manual standardizing project management policies and procedures resulting in reduced project schedules and uniform project execution.
Authored-the Commercial and the Clinical Operating Standards used across all sites eliminating duplication and standardizing process and clinical policies and procedures.
BIOLEX THERAPEUTICS 2005 2006
Senior Director of Engineering, Pittsboro, NC
Established and directed engineering department in operations, project management, process and facilities engineering, maintenance and validation of facilities and equipment for the development and manufacture of therapeutic human proteins from genetically altered Lemna.
Project Director Awarded ISPE Facility of the Year Special Merit Recognition 2006.
Managed capital plan on budget and schedule with forecasting, policies and procedures.
WYETH VACCINES 2002 2005
Senior Project Management Consultant, Sanford, NC
Managed design/construction/commissioning/validation of a $193MM multi-product bacterial vaccine manufacturing facility including fermentation, recovery, purification, and material bulk fill.
Identified $8MM in project cost savings related to logistics, manpower loading and scheduling.
Initiated a document control system for construction documents, HAZOPS, change control, risk assessment, QA operations control and unresolved design issues resulting in improved schedule.
Developed resource matrix, project control procedures and reporting reducing manpower needs.
Managed project site logistics and facilities liaison resulting in an enhanced project turnover.
PURDUE PHARMACEUTICALS 2001
Senior Director of Engineering, West Paterson, NJ
Directed capital project program, including $80MM DEA regulated Oxycontin manufacturing facility construction and $40 MM Oral Solid Dosage Facility within budget and schedule.
Prepared engineering manual, project procedures, site master plan and capital plan for five sites standardizing documentation for all sites.
BE&K ENGINEERING 2000-2001
Senior Project Manager, Morrisville, NC
Managed $7MM lab design and construction project for Bayer Corporation on time and budget.
Prepared business plans and pharmaceutical process/facilities project management proposals.
NOVARTIS PHARMACEUTICALS CORPORATION 1985-1999
Director - Engineering, East Hanover, NJ
Directed facilities management of 1MM sq. ft. Research & Development complex; laboratories, vivarium and offices; resources recovery, energy conservation and project coordination. Achieved operating cost savings of 12%, reduced operating budget from $30MM to $26.4MM the first year.
Directed project team in construction of $160MM, 385,000 sq. ft. oral solid dosage manufacturing facility from pharmacy thru packaging operations on time and budget.
Started up new Ritalin Facility with DEA oversight on time and budget.
Established manufacturing operations following project start-up/commissioning and validation. Successfully produced required performance lots without incidents or deviations.
Established safety priority, safety officer and awarded OSHA VPP Star award on back-back projects.
Initiated joint user-project-site and occupancy teams. Participated with user groups and finance to establish accurate project scope and cost. Project received Presidential recognition.
Developed, implemented and maintained project systems, policy and procedures while interacting with all of the various production, research and development, site facilities engineering, maintenance, QA and QC, Human Resources and compliance departments providing efficient project transition.
Senior Project Manager, Summit, NJ
Directed project team in design/construction/occupancy of $140MM, 440,000 sq. ft. life science research lab and animal care facility in the middle of an urban campus without causing disruption. Project completed on budget and 5 months early, saving $4MM in lease costs.
Introduced standards and practices for material and project procedures improving project efficiencies. Managed (10) direct reports including profiles, reviews and development plans.
Managed project to design/construct $12MM office building. Included major site utilities relocation.
Managed hazardous chemical waste disposal, asbestos abatement, radiological decontamination and vermin extermination certification during the removal of nine lab and animal care buildings.
Conducted planning for $25MM corporate headquarters building including site reprogramming.
Facilitated 1988-98 Summit Site Master Plan including environmental impact statement and developmental regulation analysis. Received City of Summit approval for site expansion.
Chaired 16 corporate and divisional task forces formed in response to multi-functional corporate issues. Received business excellence awards/President recognition.
Received CEO commendation for facilitating the tour of the research complex for 270 corporate executives, government officials and guests.
LUMMUS-CREST INC. 1983-1985
Project Manager, Pharmaceutical Department, Bloomfield, NJ
Developed technical proposals and in-house programs for pharmaceutical and biotech projects.
NATIONAL BROADCASTING CO 1982-1983
Project Manager, Operations and Technical Services, New York, NY
Prepared and managed $10MM divisional capital plan. Created Capital Recovery Program effectively saving $8MM in unnecessary capital expenditures.
Received recognition, appointed first ever NBC representative on RCA Capital Review Board.
Prepared 5-year master plan and award for Rockefeller Center including program justification.
C.F. BRAUN & CO. 1981-1982
Senior Sales Coordinator, Murray Hill, NJ
Launched Small Projects Task Force for twin $15MM decaffeination plant design.
Conducted technical audit of new fluorocarbon process plant caught and corrected design errors.
HOFFMANN-LAROCHE PHARMACEUTICAL 1974-1981
Senior Engineer, Belvedere, NJ
Directed various production projects including: start up of $15MM vitamin C derivatives plant with 3 independent production trains and solvent recovery.
Managed design and layout of $4.3MM QC building. Project built on time and budget.
Managed design/construction Sulfa Expansion Project that increased production 67%.
Managed design/construction of Vitamin E beadlet expansion project that double production.
Managed various infrastructure projects: emergency installation of alternate fuel source for spray dryer during energy crisis and construction of gasoline storage and distribution facility.
EDUCATION & PROFESSIONAL DEVELOPMENT
MBA Program, Rutgers University, Newark, NJ
BSME, Newark College of Engineering, Newark, NJ
Center for Creative Leadership
Ongoing Course/Seminars in safety, environmental, construction and project management
Licensed Professional Engineer - State of New Jersey
AFFILIATION & PUBLICATIONS
ISPE
Construction Industry Institute
Lessons for the Long Run, Pharmaceutical Executive, February 2001; vol. 21, no. 2
Merger - A Different Perspective, Pharmaceutical Executive, February 1999; vol.19, no. 2
Outplacement Interviewing Reversed, Pharmaceutical Engineering: Ispeak; Mar 1997
Marketing Our Strength, Pharmaceutical Technology: Dec 1993; vol. 17, no. 12
Planning Capital Control and Recovery, Pharmaceutical Engineering: Sept/Oct 1991; vol. 11, no. 5
A View of Management, Pharmaceutical Engineering: May/Jun 1986; vol. 6, no. 3
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